Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery

Thoracic surgery is a specialty dedicated to the management (diagnosis and treatment...) of conditions and lesions of the thoracic cage and its organs, excluding the heart, aorta and esophagus. It is based on 2 surgical techniques: open (by posterolateral thoracotomy) or minimally invasive endoscopic (with or without robot-assisted surgery).

Lobectomy is the most common pulmonary resection, however, regardless of the surgical option chosen, lung surgery remains a high-risk procedure, with serious adverse events that can occur later, including postoperative bleeding or hemothorax, pneumopathy or surgical site infection, pulmonary alveolar collapse, acute respiratory distress syndrome, pleural or pericardial effusion, lobar torsion or multi-organ failure, bronchial or esophageal fistulas, transient arrhythmia due to vagus nerve damage, pulmonary embolism, venous ischemia, ... and, per- and post-operative air leaks. Air leak has been reported in 25-75% of patients, which makes it the most common incident after elective lung surgery.

Although the majority of these air leaks resolve spontaneously within 48 hours (by continuous pleural drainage), certain cases persist for several days (more than 5 days). These are known as prolonged air leaks, or PAL.

The literature describes several sealing agents used to contain air leaks. The preventive use of sealants at the lung resection site seems safe and effective, since it significantly reduces the intensity and incidence of postoperative air leaks, and the time required for drain removal, Pharmaceutical gelatin-based medical devices, used for decades for their hemostatic properties, have recently been suggested for sealing pulmonary defects and preventing air leaks. Regarding the results obtained, gelatin appears to be a therapeutically effective biomaterial in lung surgery. We therefore hypothesize the effectiveness of the innovative medical device TenaTac® (Selentus Science, UK) in preventing air leak after major lung resection.

Inclusion criteria

• Patients hospitalized in the thoracic surgery departments of the investigating centers, for elective surgery,
• Lobectomy surgery requiring the use of a sealing agent,
• Adult patients (>18 years),
• Patients who have given written consent to participate in the study,
• Patients registered within the social security insurance in France.

Exclusion criteria

• Patients hospitalized in emergency,
• Patients with gelatin allergy,
• Patients undergoing other biomedical research likely to interfere with the evaluation criteria of this study
• Patients under tutorship and/or curatorship,
• Patients unable to follow the planned post-operative follow-up,
• Patients whose life expectancy is less than 1 year,
• Pregnant or breast-feeding patients.